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FDA 510(k)

CAS PSI KNEE SYSTEM

K-Number: K131409 · 2013-09-13

ApplicantOrthosoft, Inc.
Decision Date2013-09-13
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CAS PSI KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthosoft, Inc.. It received FDA 510(k) clearance on 2013-09-13 under 510(k) number K131409. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAS PSI KNEE SYSTEM?

CAS PSI KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-09-13. The listed applicant is Orthosoft, Inc.. The 510(k) number is K131409.

When did CAS PSI KNEE SYSTEM receive FDA 510(k) clearance?

CAS PSI KNEE SYSTEM received FDA 510(k) clearance on 2013-09-13, under 510(k) number K131409.

Who is the listed applicant for CAS PSI KNEE SYSTEM?

The FDA 510(k) record lists Orthosoft, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAS PSI KNEE SYSTEM?

The FDA product code for CAS PSI KNEE SYSTEM is JWH.

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Other records listing Orthosoft, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K100599CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150 MMK071929NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSALK071714NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003K060336NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002K043536NAVITRACK SYSTEM - S&N IMAGE FREE KNEEK041369NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017

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Related Devices (Code: JWH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262057GMK ExtensionMedacta International SAK260063GSPE SpacerThe General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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